RFK Jr. might be the biggest peptides fan of all. Or it could be the compounding pharmacy industry or Joe Rogan.
For a few years, compounders were profiting from marketing the most popular of these unproven peptide drugs (what I call “pop peptides”). The FDA put a halt to that in 2023. The agency at that point blocked specific peptide compounding due to lack of data and safety concerns.
So, what happens now to FDA oversight of “peptides” since compounders (and politicians and Joe Rogan, etc.) have Kennedy’s ear on peptides? You can probably guess.
I’ve been hearing for a few months that Kennedy is going to force the FDA to start allowing compounding pharmacies to make these pop peptides again. We’re talking about BPC-157, GHK-Cu, Ipamorelin, etc. The timing has been uncertain as to when there might be an announcement of the expected peptide un-ban. It seems imminent now after Kennedy recently went on Joe Rogan’s show and spilled the peptide beans.
What is happening and what does it mean?
RFK Jr. has used peptides & plans to un-ban them
Kennedy told Rogan that he’s going to make pop peptide compounding legal again within weeks. That was a few weeks ago, so a peptide un-ban could come as soon as next week. You can see a clip from Rogan’s interview with Kennedy below that’s focused on peptides. It seems the FDA will un-ban 14 peptides.
One of the other striking things about this video is that Kennedy finally admitted that he used and likes peptides.
Kennedy’s 2024 tweet saying the FDA was suppressing stem cells, peptides, and other supposedly helpful “stuff” made me think he had used pop peptides. It’s interesting to finally hear it though. Earlier Kennedy also disclosed that he got unproven stem cells.
Unproven stem cells sold by clinics and sketchy peptides are similar in some ways. They are both quite popular despite little data to back them up. In addition, they also have legit counterparts. There are proven and promising emerging stem cell therapies as well as proven peptide drugs like insulin and GLP-1s. Those hawking the unproven material often seek to benefit from public perceptions of and enthusiasm for the proven drugs.
Even if compounders can make safer versions of these peptide drugs than what’s available on the gray market (something the compounders like to argue, which is likely true), that’s no excuse for allowing compounders to market these unproven peptide drugs. There’s no reason why clinical trials shouldn’t be required first for these peptide drugs just as they are for other drugs. It seems that compounding of these pop peptides was allowed for a time only because of some loopholes in compounding regulations.
How the un-banning could play out
How could the FDA un-ban peptides?
The simplest route would be for Makary/Kennedy to just announce that they will not block compounding of these peptides despite them being in category 2 (the no -compounding box). This would be called enforcement discretion, essentially the FDA looking the other way.
Alternatively, Kennedy could proclaim that it was invalid for the FDA to previously put the peptides in Category 2, and the FDA is now simply rightly redefining them as Category 1. However, this second approach would be more complicated and could be challenged. Note, that while the FDA officially stopped using the ‘Category 1, 2, 3’ system for new compounding nominations in early 2025, the 19 peptides moved to Category 2 in 2023 (including the most popular peptides like BPC-157) remain in a state of regulatory arrest. Kennedy’s potential plan here is essentially a ‘jailbreak’—forcing the agency to move them back into the ‘Category 1’ safe harbor where compounding is permitted while under evaluation
It has also been practice that category shifts required new data, generally meaning actual good clinical trial data. As far as I know, there are no new solid data to support a shift for these peptides. Further, I’d imagine that experienced scientific officials (i.e., the real experts) at the FDA would oppose an un-ban.
Yet the peptide un-ban, one way or another, seems to be coming soon.
Rogan, Kennedy, & peptides
Several outlets covered Kennedy’s new statements on peptides including Gizmodo: RFK Jr. Tells Joe Rogan He’s About to Unleash 14 Banned Peptides.
It’s wild how Rogan just states in the video that peptides are legit and work.
Where’s the evidence?
It’s entirely anecdotal.
Willy-nilly consumer use of these peptides also doesn’t constitute safety data.
Risks of the peptide un-ban
More specifically, there are also no clearly safe or effective doses for these pop peptides.
For that reason, even if the peptides that are part of this fad could do something useful and in a safe way at a certain dose, everyone may be injecting the wrong dose, risking things like kidney or liver damage or who knows what else. Probably cancer in some cases, which could show up only many years later. Yet Kennedy and others wrongly claim that “real-world data” on people just randomly using peptides over the last five or so years is proof enough that the peptides are safe and effective. I guess they also think that this consumer use has also defined the right doses.
Those recommending specific doses of peptides have no good basis for those doses. These folks are often not doctors or scientists. Imagine taking five-times the recommended amount of ibuprofen or insulin or even aspirin.
Peptide stacks
Thousands of people may be taking potentially toxic doses of individual pop peptides or more likely toxic combinations, which are called peptide stacks. What are peptide stacks exactly? Many users don’t just take BPC-157; they “stack” it with three or four others. Since there are zero trials on these combinations, the risk of unpredictable interactions (especially with the kidneys or immune system) is exponentially higher.
Users may not even know they’ve nuked their health until many years later.
In addition, it’s a mystery to me how physicians and compounding pharmacies were supposedly rationally deciding on what doses people should get of these peptides before the ban. There are no clinical trial data on pop peptide use in humans. If Kennedy lifts the ban as expected, there will still be no solid basis for what dose could be safe or effective.
How Kennedy is wrong about peptides & the FDA
In the video, Kennedy also wrongly claimed that it was illegal for the FDA under the Biden administration to put popular peptides into category 2.
As I said, there are safety concerns about these peptides in addition to a general lack of data on their properties in humans. Placing certain peptides temporarily in category 2 was well within the FDA’s legal power.
It seems that at least two things are happening here with this anticipated un-banning of peptides. First, Kennedy personally believes in peptides and listens to others who do likewise, which apparently trumps any need for actual good data. Second, the compounding pharmacy industry, which profited from these peptides and seeks to again, seems to have a friend in Kennedy. Putting these two things together is like an equation that will yield profits to compounders and risks to the public.
There should be no double standard for oversight of different peptide drugs just because substances like BPC-157 were proposed for compounding as well as being profitable and popular.
The un-ban also risks undermining the FDA drug oversight system. What’s to stop people from nominating certain as-yet unproven drugs for compounding and then some firms market them while they sit in regulatory limbo?
Notes
For more details check out: The peptide craze sweeping America has a fan in RFK Jr.
Peptides are tiny signalling molecules which are naturally in your body and have been in use for a long time. Do you have any examples of harm, or are you just stating “what could happen”?